Implantable intravascular access system

• US 4,846,806 A
• Filed: 10/06/1987
• Issued: 07/11/1989
• Est. Priority Date: 10/06/1987
• Status: Expired due to Term

• Current Assignee: Regents of The University of Minnesota (University of Minnesota)
• Original Assignee: 501 Regents of University of Minnesota
• Inventors: Wigness, Bruce D., Dorman, Frank D.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Lewis, Ralph
• Application Number:
  US07/105,740
• Time in Patent Office: 644 Days
• Field of Search: 604/27-30, 604/43, 604/96-99, 604/151, 604/153, 604/174, 604/175, 604/256, 604/278, 604/280, 604/283, 604/891.1
• US Class Current: 604/175
• CPC Class Codes: A61M 2039/0226 having means for protecting the interior of the access site from damage due to the insertion of a needle
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276

Abstract

An implantable intravascular access system, including an implantable, catheter obturator controller manifold for use with an implantable intravascular catheter. The catheter includes a lumen, having an expanded state and a normal state, an obturator, and an obturator plenum having an inflated state and a contracted state. The lumen can be closed or opened by hydraulically actuating the expansion or contraction of the obturator plenum when the lumen is in its normal state. When the obturator plenum is expanded to its inflated state, the obturator substantially blocks the lumen such that substantially no fluid can pass through the lumen when the lumen is in its normal state. The manifold comprises a housing, a receiving mechanism for receiving the catheter, an actuating mechanism for hydraulically actuating the expansion or contraction of the plenum, and a first entry mechanism for entering the housing.

Claims

1. An implantable, catheter obturator controller manifold for use with an implantable intravascular catheter including a lumen having a normal state and an expanded state, an obturator, and an obturator plenum having an inflated state and a contracted state, wherein the lumen can be closed or opened when it is in its normal state by hydraulically actuating the expansion or contraction of the obturator plenum, wherein when the obturator plenum is expanded to its inflated state, the lumen is substantially blocked by the obturator when the lumen is in its normal state such that substantially no fluid can pass through the lumen, the manifold comprising:

(a) a housing;

(b) first entry means for entering the housing;

(c) receiving means for receiving the catheter in the housing; and

(d) actuating means for hydraulically actuating the contraction or expansion of the obturator plenum, said actuating means including;

(i) a manifold chamber within the housing in fluid communication with the catheter, said manifold chamber including at least two subchambers separated from each other, a fluid pathway subchamber adapted for fluid communication with the lumen of the catheter and the first entry means, and a hydraulic fluid subchamber in fluid communication with the obturator plenum;

said fluid pathway subchamber and said hydraulic fluid subchamber being expandable and contractible; and

(ii) an amount of a hydraulic fluid effective to actuate the expansion and contraction of the obturator plenum, said fluid being adapted to be contained within the hydraulic fluid subchamber and the obturator plenum, and said amount of fluid being sufficient to allow the obturator to effectively block the lumen when the lumen is in its normal state and the obturator is expanded to its inflated state.

2. The implantable, catheter obturator controller manifold of claim 1 wherein said first entry means include a puncturable, self-sealing, resilient access septum which seals said first entry means.

3. The implantable, catheter obturator controller manifold of claim 2 including adjusting means for adjusting the amount of hydraulic fluid within the hydraulic fluid subchamber and the obturator plenum.

4. The implantable, catheter obturator controller manifold of claim 3 wherein said adjusting means include second entry means for entering said housing;

said second entry means being in fluid communication with said hydraulic fluid subchamber;

said second entry means including a puncturable, self-sealing, resilient priming septum which seals said second entry means;

wherein the amount of hydraulic fluid in said hydraulic fluid subchamber may be adjusted by infusing fluid into, or withdrawing fluid from, said hydraulic fluid subchamber using a hypodermic needle inserted through said priming septum.

5. The implantable, catheter obturator controller manifold of claim 2 wherein said actuating means include a separation diaphragm between the hydraulic fluid subchamber and the fluid pathway subchamber having first and second stable positions;

said fluid pathway subchamber being adapted to communicate with the catheter lumen via a catheter passageway opening;

wherein the separation diaphragm cooperates with the hydraulic fluid in the hydraulic fluid subchamber and the obturator plenum to expand the obturator plenum to its inflated state such that the obturator substantially blocks the catheter lumen when the diaphragm is in the first stable position and the lumen is in its normal state, and to contract the obturator plenum such that the catheter lumen is open when the diaphragm is in the second stable position.

6. The implantable, catheter obturator controller manifold of claim 5 wherein said actuating means include check valve means for blocking fluid communication between the fluid pathway subchamber and the catheter lumen via the catheter passageway opening such that a surge of fluid pressure into said fluid pathway subchamber closes said check valve means such that fluid cannot pass into the catheter lumen from the fluid pathway subchamber, wherein the surge of fluid pressure effectively manipulates the separation diaphragm from the second stable position to the first stable position, thereby expanding the obturator plenum to its inflated state and substantially blocking the catheter lumen when the lumen is in its normal state.

7. The implantable, catheter obturator controller manifold of claim 5 wherein said actuating means include orifice restricting means for restricting fluid communication between the fluid pathway subchamber and the catheter lumen via the catheter passageway opening such that a surge of fluid pressure into said fluid pathway subchamber effectively manipulates the separation diaphragm from the second stable position to the first stable position, thereby expanding the obturator plenum to its inflated state such that the obturator substantially blocks the catheter lumen when the lumen is in its normal state.

8. The implantable, catheter obturator controller manifold of claim 2 wherein said actuating means include first expansion means for expanding and contracting said hydraulic fluid subchamber such that the hydraulic fluid subchamber can be expanded so that said fluid is at least partially withdrawn from the obturator plenum, thereby contracting the obturator plenum and opening the catheter lumen, and such that, subsequently, the hydraulic fluid subchamber can be contracted such that said fluid expands the obturator plenum to its inflated state, the obturator substantially blocks the catheter lumen when the lumen is in its normal state, and substantially no fluid can diffuse through the lumen.

9. The implantable, catheter obturator controller manifold of claim 8 wherein said actuating means include an expansion subchamber;

said expansion subchamber having an expandable and contractable volume;

said volume being at least partially occupied by a compressible gas;

wherein said expansion subchamber cooperates with said hydraulic fluid subchamber to allow the expansion of the hydraulic fluid subchamber into space occupied by said expansion subchamber.

10. The implantable, catheter obturator controller manifold of claim 9 wherein said actuating means include second expansion means for expanding and contracting said fluid pathway subchamber;

wherein said second expansion means cooperates with said first expansion means and said expansion subchamber, such that the expansion or contraction of the volume of said expansion subchamber is substantially equivalent to the contraction or expansion of the fluid pathway subchamber and the hydraulic fluid subchamber taken together

11. The implantable, catheter obturator controller manifold of claim 10 wherein said actuating means include a first bellows mechanism including a first bellows and a rigid bellows diaphragm, wherein the first bellows is attached to the bellows diaphragm and the housing such that the first bellows and the diaphragm separate the hydraulic fluid subchamber from the expansion subchamber.

12. The implantable, catheter obturator controller manifold of claim 11 wherein said acuating means include a second bellows mechanism including a second bellows, wherein the second bellows is attached to the bellows diaphragm and the housing such that the second bellows separates said fluid pathway subchamber from said hydraulic fluid subchamber.

13. The implantable, catheter obturator controller manifold of claim 11 wherein said actuating means include telescoping means for separating said fluid pathway subchamber from said hydraulic fluid subchamber, said telescoping means including a cylindrical piston inside of a sleeve of slightly larger diameter;

said piston equipped with at least one resilient O-ring located on the cylindrical surface of the piston such that the piston, the O-ring, and the sleeve cooperate to form an expandable telescoping joint which is sealed to said bellows diaphragm and to said housing to substantially prevent fluid communication between the fluid pathway subchamber and the hydraulic fluid subchamber.

14. The implantable, catheter obturator controller manifold of claim 2 wherein said actuating means include a separation diaphragm between the hydraulic fluid subchamber and the fluid pathway subchamber having a single stable position;

said fluid pathway subchamber communicating with the catheter lumen via a catheter passageway opening;

wherein the separation diaphragm cooperates with the hydraulic fluid in the hydraulic fluid subchamber and the obturator plenum to expand the obturator plenum to its inflated state such that the obturator substantially blocks the catheter lumen when the diaphragm is in the stable position and the lumen is in its normal state; and

wherein a surge of fluid pressure away from said separation diaphragm can move said diaphragm away from the stable position thereby expanding the hydraulic fluid subchamber and contracting the obturator plenum such that the catheter lumen is open for fluids to pass through.

15. The implantable catheter obturator controller manifold of claim 14 wherein said actuating means include orifice restricting means for restricting fluid communication between the fluid pathway subchamber and the catheter lumen via the catheter passageway opening such that a surge of fluid pressure withdrawn from said fluid pathway subchamber is effective to create a transient pressure drop across said restricting means and such that the pressure drop facilitates the opening of the catheter lumen;

and wherein the catheter lumen is adapted to be expanded to its expanded state when the obturator plenum is in its inflated state by infusing fluids into the fluid pathway subchamber under sufficient pressure to expand the catheter thereby allowing fluids to pass through the lumen when the obturator plenum is in its inflated state.

16. An implantable intravascular access system comprising:

(a) a flexible intravascular catheter including a lumen having a normal state and an expanded state, an obturator, and an obturator plenum having an inflated state and a contracted state, wherein the lumen can be closed or opened by hydraulically actuating the expansion or contraction of the obturator lumen, wherein the lumen is substantially blocked by the obturator such that substantially no fluid can pass through the lumen when the obturator plenum is expanded to its inflated state and the lumen is in its normal state;

(b) a housing;

(c) first entry means for entering the housing;

(d) receiving means for receiving the catheter in the housing; and

(e) actuating means for hydraulically actuating the contraction or expansion of the obturator plenum, said actuating means including;

(i) a manifold chamber within the housing in fluid communication with the catheter, said manifold chamber including at least two subchambers separated from each other, a fluid pathway subchamber in fluid communication with the lumen of the catheter and the first entry means, and a hydraulic fluid subchamber in fluid communication with the obturator plenum;

said fluid pathway subchamber and said hydraulic fluid subchamber being expandable and contractable; and

(ii) an amount of a hydraulic fluid effective to actuate the expansion and contraction of the obturator plenum, said fluid being contained in the hydraulic fluid subchamber and the obturator plenum, and said amount of fluid being sufficient to allow the obturator to effectively block the lumen when the lumen is in its normal state and the obturator plenum is expanded to its inflated state.

17. The implantable intravascular access system of claim 16 including adjusting means for adjusting the amount of hydraulic fluid within the hydraulic fluid subchamber and the obturator plenum;

said adjusting means including second entry means for entering the housing which communciate with said hydraulic fluid subchamber;

said first entry means including a puncturable, self-sealing, resilient access septum which seals said first entry means; and

said second entry means including a puncturable, self-sealing, resilient priming septum which seals said second entry means;

said fluid pathway subchamber communicating with the catheter lumen via a catheter passagway opening;

wherein said amount of hydraulic fluid in said hydraulic fluid subchamber and said obturator plenum may be adjusted by infusing fluid into, or withdrawing fluid from, said hydraulic fluid subchamber using a hypodermic needle inserted through said priming septum.

18. The implantable intravascular access system of claim 17 wherein said actuating means include a separation diaphragm having first and second stable positions and orifice restricting means for restricting fluid communication between the fluid pathway subchamber and the catheter lumen via the catheter passageway opening;

wherein the separation diaphragm cooperates with the hydraulic fluid in the hydraulic fluid subchamber and the obturator plenum to expand and contract the obturator plenum such that the obturator substantially blocks the catheter lumen when the lumen is in its normal state and the separation diaphragm is in the first stable position, and such that the obturator plenum contracts such that the catheter lumen is open when the separation diaphragm is in the second stable position; and

wherein said orifice restricting means can restrict communication between the fluid pathway subchamber and the catheter lumen via the catheter passageway opening, such that a surge of fluid pressure into said fluid pathway subchamber effectively manipulates the separation diaphragm from the second stable position to the first stable position, thereby fully expanding the obturator plenum to its inflated state and substantially blocking the catheter lumen when the lumen is in its normal state.

19. The implantable, intravascular access system of claim 18 wherein said actuating means include a first bellows mechanism including a first bellows and a rigid bellows diaphragm;

said first bellows being attached to the bellows diaphragm and the housing such that the first bellows and the diaphragm separate the hydraulic fluid subchamber from the expansion subchamber.

20. The implantable, intravascular access system of claim 19 wherein said actuating means include a second bellows mechanism including a second bellows;

said second bellows being attached to the bellows diaphragm and the housing such that the second bellows separates said fluid pathway subchamber from said hydraulic fluid subchamber.

21. The implantable, intravascular access system of claim 19 wherein said actuating means include telescoping means for separating said fluid pathway subchamber from said hydraulic fluid subchamber, said telescoping means including a cylindrical piston inside of a sleeve of slightly larger diameter, said piston equipped with at least one resilient O-ring located on the cylindrical surface of the piston such that the piston, the O-ring, and the sleeve cooperate to form an expandable telescoping joint which is sealed to said bellows diaphragm and to said housing to substantially prevent fluid communication between the fluid pathway subchamber and the hydraulic fluid subchamber.

22. The implantable intravascular access system of claim 18 wherein said catheter lumen can be expanded to the expanded state when the obturator plenum is in its inflated state and fluid is infused into the fluid pathway subchamber with sufficient fluid pressure to expand the catheter, thereby allowing fluid to pass through the lumen when the obturator plenum is in its inflated state.

23. The implantable intravascular access system of claim 17 wherein said actuating means include an expansion subchamber;

first expansion means for expanding and contracting said hydraulic fluid subchamber; and

second expansion means for expanding and contracting said fluid pathway subchamber;

said expansion subchamber containing an expandable and contractible volume;

said volume being at least partially occupied by a compressible gas;

wherein said second expansion means cooperate with said first expansion means and said expansion subchamber, such that the expansion or contraction of the volume of said expansion subchamber substantially relates to the contraction or expansion of the fluid pathway subchamber and the hydraulic fluid subchamber together; and

wherein the hydraulic fluid subchamber may be expanded such that fluid is withdrawn from the obturator plenum, thereby contracting the obturator plenum and opening the catheter lumen, and such that the hydraulic fluid subchamber may be subsequently contracted such that the fluid expands the plenum to its inflated state, causing the obturator to substantially block the lumen when the lumen is in its normal state such that substantially no fluid can pass through the lumen.

24. The implantable intravascular access system of claim 16 wherein said actuating means include a separation diaphragm between the hydraulic fluid subchamber and the fluid pathway subchamber having a single stable position;

said fluid pathway subchamber communicating with the catheter lumen via a catheter passageway opening;

wherein the separation diaphragm cooperates with the hydraulic fluid in the hydraulic fluid subchamber and the obturator plenum to expand the obturator plenum to its inflated state such that the obturator substantially blocks the catheter lumen when the diaphragm is in the stable position and the lumen is in its normal state; and

wherein a surge of fluid pressure away from said separation diaphragm can move said diaphragm away from the stable position thereby expanding the hydraulic fluid subchamber and contracting the obturator plenum such that the catheter lumen is open for fluid to pass through.

25. The implantable catheter obturator controller manifold of claim 24 wherein said actuating means include orifice restricting means for restricting fluid communication between the fluid pathway subchamber and the catheter lumen via the catheter passageway opening such that a surge of fluid pressure withdrawn from said fluid pathway subchamber is effective to create a transient pressure drop across said restricting means and such that the pressure drop facilitates the opening of the catheter lumen;

and wherein the catheter lumen can be expanded to its expanded state when the obturator plenum is in its inflated state by infusing fluids into the fluid pathway subchamber under sufficient pressure to expand the catheter, thereby allowing fluids to pass through the lumen when the obturator plenum is in its inflated state.

26. The implantable intravascular access system of claim 16 wherein said actuating means include a separation diaphragm having first and second stable positions and check valve means for blocking fluid communication between the fluid pathway subchamber and the catheter lumen via the catheter passageway opening;

wherein the separation diaphragm cooperates with the hydraulic fluid in the hydraulic fluid subchamber and the obturator plenum to expand and contract the obturator plenum such that the obturator substantially blocks the catheter lumen when the separation diaphragm is in the first stable position and the lumen is in its normal state and such that the obturator plenum contracts such that the catheter lumen is open when the separation diaphragm is in the second stable position; and

wherein said check valve means can block communication between the fluid pathway subchamber and the lumen of the catheter via the catheter passageway opening, such that a surge of fluid pressure into said fluid pathway subchamber closes said check value means such that fluid cannot pass into the catheter lumen from the fluid pathway subchamber, and wherein the urge of fluid pressure can more effectively manipulate the separation diaphragm from the second stable position to the first stable position, thereby expanding the obturator plenum to its inflated state and substantially blocking the catheter lumen when the lumen is in its normal state.